Atlas FDA

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

FDA 510(k) clearance K042643 · decided 2004-11-18

Clearance details

K-number
K042643
Device name
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2004-09-27
Decision date
2004-11-18
Days to decision
52 days
Clearance type
Traditional
Product code
DCF
Device class
2
Regulation number
866.5040
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ortho-Clinical Diagnostics

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Optilite Low Level Albumin Kit (K153560)The Binding Site Group , Ltd.2016-08-25
Human Microalbumin kit for use on SPAPLUS (K143118)The Binding Site Group , Ltd.2015-05-26
Urine/CSF Albumin, Urine/CSF Albumin Calibrator (K142346)Beckman Coulter Ireland, Inc.2014-10-15
HUMAN ALBUMIN CSF KIT (K121045)The Binding Site Group , Ltd.2013-06-19
TINA-QUANT ALBUMIN GEN.2 (K113072)Roche Diagnostics Operations2012-05-14
EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (K101089)Medica Corp.2011-07-13
TINA-QUANT ALBUMIN GEN 2 (K101203)Roche Diagnostics2010-09-10
COBAS 8000 MODULAR SERIES ANALYZER (K100853)Roche Diagnostics Corp.2010-09-09
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR (K091486)Kamiya Biomedical Co.2010-04-29
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 (K082251)Beckman Coulter, Inc.2009-04-08
DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL (K061990)Dade Behring, Inc.2006-09-19
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (K053553)Polymedco, Inc.2006-03-09

Recalls involving this device

RecordFirmDate
VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITR recall (Z-0971-2012)Ortho-Clinical Diagnostics2012-02-07

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19